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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL FOR 8MM, 1,35X54MM, STRYKER-SHAFT; DISPOSABLE
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STRYKER LEIBINGER FREIBURG DRILL FOR 8MM, 1,35X54MM, STRYKER-SHAFT; DISPOSABLE Back to Search Results
Model Number 60-14008
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/13/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
 
Event or Problem Description
It was reported by a company representative that during the procedure, the surgeon was drilling into plate with drill in which the drill bit chipped off the chipped piece could not be located and a x-ray was done post operatively in which it was still not located.The surgeon believes the piece was suctioned during the procedure.There is no other information at this time.
 
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Brand Name
DRILL FOR 8MM, 1,35X54MM, STRYKER-SHAFT
Common Device Name
DISPOSABLE
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
GM  D-79111
MDR Report Key11732443
Report Number0008010177-2021-00021
Device Sequence Number3909716
Product Code HBE
UDI-Device Identifier07613154183937
UDI-Public07613154183937
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K070876
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number60-14008
Device Catalogue Number60-14008
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/13/2021
Initial Report FDA Received Date04/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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